LITe DECOMPRESSION 48089999

GUDID 07613327064926

LIGHT CABLE

Stryker Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 07613327064926
• NIH Device Record Key: f2fd22da-7690-44e0-a25b-ff620bf18d7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITe DECOMPRESSION
• Version Model Number: 48089999
• Catalog Number: 48089999
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327064926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122637

FDA Product Code

• FST: LIGHT, SURGICAL, FIBEROPTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-09-24

On-Brand Devices [LITe DECOMPRESSION]

• 07613327064926: LIGHT CABLE
• 07613327470864: Specialty LITe Decompression Long Tube Set
• 07613327470857: Specialty LITe Decompression Tube Set
• 07613327488814: Specialty LITe Decompression Modified Snake Arm Clamp
• 07613327486346: Specialty LITe Decompression Beveled Tube Set
• 07613327482843: Specialty LITe Decompression Initial Dilator No Cannulation
• 07613327119947: TRAY INSERT - TUBES
• 07613327119930: DECOMPRESSION TUBES CONTAINER - BASE AND LID
• 07613327119923: TRAY INSERT - TUBES
• 07613327119039: AUXILLIARY CONTAINER